FDA Approves Wegovy as First Once-Weekly Injection for Obesity-Linked Liver Disease

Wegovy (semaglutide) is a once-weekly injection that was first approved in 2017 to help with weight loss and lower the risk of heart problems.Now, the FDA has approved it to treat a liver condition called metabolic dysfunction-associated steatohepatitis (MASH) in adults whose livers have significant scar tissue but haven’t yet developed severe liver damage (cirrhosis).Wegovy should be combined with a low-calorie diet and more active lifestyle.

MASH affects about 1 in 20 people in the U.S., and it’s more common in people who are overweight or have obesity.

MASH, which used to be called nonalcoholic steatohepatitis (NASH), is a serious liver disease caused by a buildup of fats in the liver.

Closely tied to obesity, type 2 diabetes, high levels of unhealthy fats, and other metabolic factors, MASH often goes unnoticed due to the lack of early symptoms. Over time, it causes liver inflammation and scarring, leading to serious damage that may trigger weight loss, fatigue, and muscle weakness. If left untreated, MASH can progress to cirrhosis, liver failure, or even liver cancer. In some cases, a liver transplant may be needed. This approval is important because Wegovy is the first medicine in its class (GLP-1 receptor agonist) to be approved for treating MASH. It works by mimicking a natural hormone in your body that helps control appetite and blood sugar levels. This may help reduce both liver inflammation and body weight. Until now, there were no FDA-approved treatments for MASH.

Wegovy was approved based on early results from an ongoing study, which showed that it improved MASH without worsening liver damage – especially when combined with lifestyle changes and specific medicines for treating related metabolic illnesses (for example, diabetes). The ongoing study involves adults who have MASH, have moderate to advanced liver scarring, and who were given either Wegovy or a placebo along with a reduced-calorie diet and exercise plan. At 72 weeks, the early results showed that a greater number of people taking Wegovy vs. a placebo no longer showed signs of MASH, without their liver scarring worsening (63% vs. 34%). Also, more people on Wegovy, compared to those on a placebo, showed an improvement in liver scarring with no MASH progression (37% vs. 22%). About 33% of people taking Wegovy, compared to 16% on a placebo, had both benefits – less liver inflammation and improved liver scarring. The trial will continue to 240 weeks to find out if these gains lead to fewer deaths, liver transplants, and other liver‐related problems. Common side effects include headaches, tiredness, dizziness, nausea, vomiting, diarrhea, constipation, indigestion, abdominal (belly) pain, feeling bloated, belching, flatulence, acid reflux, and stomach flu. Others include cold-like symptoms and low blood sugar levels (especially if you have type 2 diabetes). More serious side effects include inflammation of the pancreas, gallbladder problems, low blood sugar levels (especially when taken with insulin), kidney problems from dehydration, severe stomach problems, allergic reactions, eye complications in people with diabetes, a higher heart rate, and depression or suicidal thoughts. Wegovy caused thyroid tumors in mice and rats, but it is unknown whether Wegovy causes thyroid tumors in humans.

Wegovy is given as a shot under the skin once a week. You can inject it into your belly, thigh, or upper arm. You’ll start with a low dose that increases slowly over time. This helps reduce stomach-related side effects. Most people will reach a weekly dose of 2.4 mg, but some may stay at 1.7 mg if they can’t tolerate the higher dose. You should use Wegovy along with a low-calorie diet and more physical activity. Rotate your injection site and take Wegovy weekly on the same day, at any time of the day. If you miss a dose, take it if the next dose is over two days away; otherwise, skip it. For missed doses over two weeks, follow your health care provider’s advice. Wegovy is not recommended if you or someone in your family has had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN2). These risks are based on findings from animal studies and past reports with similar medicines. You should tell your health care provider if you have problems with your kidneys or pancreas, type 2 diabetes and related eye problems, mental health issues, or are allergic to semaglutide or any of the ingredients in Wegovy before starting your treatment. It is important to let your health care provider know if you are taking Wegovy before any surgery or deep sedation because of a risk of lung problems caused by breathing in stomach contents. Wegovy may slow down how your stomach empties, which can affect how other medicines are absorbed. Be sure to tell your health care provider about all the medicines you take, including over-the-counter products and supplements. Wegovy can harm an unborn baby and may enter breast milk. Let your health care provider know if you are pregnant or are breastfeeding. You should stop using Wegovy for at least two months before trying to get pregnant.